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Phase 2 Completed N=110 Randomized Double-blind Treatment

A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).

Source: ClinicalTrials.gov NCT00768079 ↗
Enrolled (actual)
110
Serious AEs
25.5%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Participants With Asthma Exacerbations at Week 12 — 38.9; 25.0; 41.7; 38.9 percentage of participants — p=0.312

Summary

The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Asthma Exacerbations at Week 12
38.9; 25.0; 41.7; 38.9; 25.0; 41.7 0.312
SECONDARY
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
30; 32; 30; 9; 8; 11
SECONDARY
Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24
22.2; 11.1; 22.2; 22.2; 11.1; 22.2 0.343
SECONDARY
Asthma Control Questionnaire (ACQ) Scores
3.69; 3.72; 3.26; 1.89; 1.89; 1.52
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites
1.696; 1.689; 2.067; 2.008; 2.003; 2.254
SECONDARY
Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home
1.6346; 1.7119; 1.8404; 1.7800; 1.8562; 1.7674
SECONDARY
Peak Expiratory Flow (PEF) Recorded at Home
161.845; 179.000; 177.929; 175.093; 186.538; 172.811
SECONDARY
Number of Puffs of Rescue Beta-2 Agonist Per Week
1.95; 1.74; 1.47; 1.80; 1.63; 1.38
SECONDARY
Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84
9; 10; 10; 12; 19; 16
SECONDARY
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
3.14; 3.18; 3.35; 4.74; 4.76; 5.16
SECONDARY
Number of Healthcare Resources Utilized by Resource Type
64; 40; 43; 2; 0; 0
SECONDARY
Maximum Observed Serum Concentration (Cmax) for Benralizumab
7.03; 26.7
SECONDARY
Area Under the Serum Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) for Benralizumab
65.7; 263
SECONDARY
Area Under the Serum Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUC [0 - Infinity]) for Benralizumab
67.1; 268
SECONDARY
Systemic Clearance (CL) for Benralizumab
4.92; 3.97
SECONDARY
Terminal Phase Elimination Half-Life (t1/2) for Benralizumab
11.5; 13.2
SECONDARY
Volume of Distribution of the Central Compartment (Vc) for Benralizumab
46.4; 39.8
SECONDARY
Volume of Distribution at Steady State (Vss) for Benralizumab
71.8; 64.0
SECONDARY
Number of Participants With Anti-Drug Antibodies to Benralizumab
1; 0; 2; 4

Eligibility Criteria

Inclusion Criteria

  • Male or female subjects aged 18 to 60 years at the time of the administration of investigational product
  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
  • Physician-diagnosed asthma with a duration of greater than or equal to (>=) 2 years by medical chart or subject report
  • Had an asthma exacerbation requiring urgent care in the year prior to screening
  • Meets National Heart, Lung, and Blood Institute (NHLBI) for persistent asthma in the 3 months prior to the current urgent healthcare visit
  • Current asthma exacerbation that must have lasted >= 2 hours prior to arrival to the urgent healthcare setting
  • Requires at least 2 treatments of inhaled bronchodilators for the current asthma exacerbation in the urgent healthcare setting or within the emergency medical system (EMS) for >= 1 hour
  • Shows an FEV1 or PEF of not more than 70 percent (%) predicted after 1 hour of treatment of the current asthma exacerbation
  • Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) from screening through the end of the study (Day 84; Cessation of birth control after this point should be discussed with a responsible physician)
  • Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Day 0 through Day 84
  • Otherwise healthy by medical history and physical examination
  • A chest x-ray that is normal for an asthmatic population and excludes alternative diagnosis per the investigation
  • Ability to complete the follow-up period until Day 168 as required by protocol
  • The investigator has determined that the subject is clinically stable and the FEV1, is >= 30% predicted prior to receiving investigational product on Day 0.

Exclusion Criteria

  • Known history of allergy or reaction to any component of the investigational product formulation
  • Acute illness other than asthma at the start of the study
  • Fever more than (>) 38.6 degrees Celsius (C) (>101.5 degrees Fahrenheit [F])
  • Current acute asthma attack is due to aspirin-induced asthma
  • Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute bronchospasm
  • Evidence of clinically significant non-respiratory active infection, including ongoing chronic infection
  • History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in stools or have minor symptoms and have exposure to stream or lake water, been exposed to someone who has a parasitic infection (like a family member), or study subject has traveled outside the United States of America (USA) and/or Canada within the last year
  • Use of immunosuppressive medication (except oral prednisone and inhaled and topical corticosteroids) within 30 days before randomization into the study
  • Have received Xolair within 6 months before randomization into the study
  • Receipt of immunoglobulin or blood products within 30 days before randomization into the study
  • Receipt of any investigational drug therapy within 6 months before the first dose of investigational product in this study through Day 168
  • History of primary immunodeficiency
  • Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
  • History of clinically significant abnormality on ECG in the opinion of the investigator
  • Pregnancy (must have a negative
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00768079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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